Director, External QC Testing & Program Management (Remote)

TG Therapeutics, Inc.; Northern (KY); Hybrid; USD 170,000 - 210,000; Full time

Job summary

TG Therapeutics, Inc. is seeking an Associate Director/Director of Program Management for QC Testing, focusing on outsourced analytical/testing activities with CDMOs, ensuring timely delivery of quality data for development and regulatory submissions.

This remote role interfaces with external partners and internal stakeholders across QA, Regulatory, and Operations. The ideal candidate has 12+ years in biotech/pharma, 3+ years managing CDMOs or external labs, and strong GMP/GLP knowledge;

Qualifications

• 12+ years in biotechnology, pharmaceutical, or life sciences industries.
• 3+ years supplier management, external manufacturing, or outsourced testing oversight.
• Experience managing CDMOs and contract testing laboratories.
• Strong understanding of QC testing within biologics, cell therapy, gene therapy, vaccines, and/or pharmaceutical products.
• Experience supporting clinical and/or commercial product development programs.

Responsibilities

• Serve as the primary relationship manager for external laboratories, CMOs, CDMOs, and contract testing vendors.
• Establish and maintain productive partnerships with testing organizations.
• Monitor supplier performance against quality, delivery, cost, and compliance metrics.
• Lead regular business reviews with testing partners.
• Collaborate with Quality Assurance to manage supplier qualification and ongoing oversight activities.
• Lead contract negotiations, Statements of Work (SOWs), change orders and budget management.

Skills

Supplier management

External testing oversight

Project management

GMP/GLP

Cross-functional collaboration

Budget management

Education

Bachelor's degree in Biology/ Chemistry/ Biotech/ Pharmaceutical Sciences

Advanced degree (MS/PhD/MBA) preferred

Job description

TG Therapeutics, Inc. is seeking an Associate Director/Director of Program Management for QC Testing, focusing on outsourced analytical/testing activities with CDMOs, ensuring timely delivery of quality data for development and regulatory submissions.

This remote role interfaces with external partners and internal stakeholders across QA, Regulatory, and Operations. The ideal candidate has 12+ years in biotech/pharma, 3+ years managing CDMOs or external labs, and strong GMP/GLP knowledge;